A Phase 3 Study of Tezacaftor (VX-661) in Combination With Ivacaftor (VX-770) in Subjects Aged 12 Years and Older With Cystic Fibrosis (CF), Who Have One F508del-CFTR Mutation and a Second Mutation That Has Been Demonstrated to be Clinically Respons
Completed
Vertex Pharmaceuticals Incorporated
Phase 3
2015-06-01
This is a Phase 3, randomized, double-blind, ivacaftor-controlled, parallel-group,
multicenter study of tezacaftor in combination with ivacaftor in subjects aged 12 years and
older with CF who are heterozygous for the F508del-CFTR mutation and a second CFTR allele
with a gating defect that is clinically demonstrated to be ivacaftor responsive.
A Phase 2 Study to Evaluate Effects of VX-661/Ivacaftor on Lung and Extrapulmonary Systems in Subjects With Cystic Fibrosis, Homozygous for the F508del-CFTR Mutation
Completed
Vertex Pharmaceuticals Incorporated
Phase 2
2016-02-01
To evaluate the clinical mechanisms of action in lung and extrapulmonary systems of VX-661
(tezacaftor; TEZ) in combination with ivacaftor (IVA) (TEZ/IVA) in participants with cystic
fibrosis (CF) who are homozygous for the F508del mutation on the CF transmembrane conductance
regulator (CFTR) gene.
A Study to Evaluate the Effect of VX-661 in Combination With Ivacaftor on Chest Imaging Endpoints in Subjects With Cystic Fibrosis, Homozygous for the F508del CFTR Mutation
Completed
Vertex Pharmaceuticals Incorporated
Phase 2
2016-09-01
The primary purpose of study is to evaluate the treatment effect of tezacaftor in combination
with ivacaftor (TEZ/IVA) on chest imaging endpoints using low-dose computed tomography (LDCT)
at Week 72, and to evaluate the safety of TEZ/IVA through Week 72.
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